FDA, drug industry re-negotiate user fees

The pharmaceutical industry is in the process of negotiating the fourth version of the Prescription Drug User Fee Act (PDUFA) with the FDA, as the current agreement is due to expire at the end of 2007. The biggest proposed change would be for drug companies to pay additional fees that would be used to fund post-marketing drug safety studies. "Until now, user fees paid by firms have primarily been used to review the safety and efficacy of new drugs before they are approved to be sold on the market," notes In-PharmaTechnologist. But in the wake of the Vioxx disaster, post-marketing studies--which are used to determine the long-term effects and unanticipated complications from a drug--have received renewed attention. A recent study found that two-thirds of the post-approval drug trials promised by drug developers have never been started despite the fact that developers promised to undertake the studies in order to gain an approval.

In addition to new fees to fund post-marketing studies, the FDA has reached a deal with drug companies that will require the industry to pay fees for the agency to review TV ads. The money will be used to hire new staffers in order to speed the review process. Both Health and Human Services and Congress must agree to the deals before they can take effect.

- read this report [1] from In-PharmaTechnologist
- check out the Wall Street Journal article [2] (sub. req.)

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Analysis shows post-marketing studies ignored. Report [4]
Pharmacovigilance Grows in Importance. Report [5]